May

2012

Cl ll Varian True Beam

Company: Varian Medical Systems, Inc.
Date of Enforcement Report 5/23/12
Class ll:

PRODUCT
True Beam; Versions 1.0, 1.5.12.0 and below, 1.6.9.5 and below. Product Usage: TrueBeam Radiotherapy delivery system is intended to provide sterotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated. Model number H19. Recall # Z-1495-2012

REASON
A software anomaly has been identified in TrueBeam when using respiratory gating with patients in the prone position. The gating curve is inverted when a prone patient plan is loaded into TrueBeam.

RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter dated April 13, 2012. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
207 devices

DISTRIBUTION
Nationwide and Internationally

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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Cl ll Varian True Beam

Amy Sellers

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